A Phase 2 Study of Pasireotide in People With Prolactinoma

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Full Title

Pasireotide Treatment for Patients with Prolactinomas Who Need Treatment Beyond Dopamine Agonist Therapy

Purpose

The purpose of this study is to see if the drug pasireotide works well to treat prolactinomas. Prolactinomas are noncancerous pituitary gland tumors that make too much prolactin. Prolactin is a hormone that causes the body to make less estrogen and testosterone (sex hormones).

The people in this study have prolactinoma that keeps growing or has only partially responded to dopamine agonist therapy. Dopamine agonists are drugs that stop your body from making too much prolactin. They can shrink prolactinomas.

Pasireotide attaches to somatostatin receptors (SSTRs), which are proteins that play a role in decreasing hormones, including prolactin. After attaching to SSTRs, pasireotide reduces prolactin production. It is given as an injection into the buttock muscle every 4 weeks.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have prolactinoma that had not responded well to dopamine agonist therapy and cannot be taken out with surgery.
  • Have completed any prior radiation therapy at least 6 months before getting pasireotide; octreotide or lanreotide at least 8 weeks earlier; chemotherapy at least 4 weeks earlier; temozolomide at least 3 weeks earlier; and any other anti-cancer drugs at least 4 weeks earlier.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Eliza Geer’s office at 646-608-3797.

Protocol

23-371

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT06295952